An observational study in Food Insecurity and Overweight and Obesity, sponsored by University of New Hampshire. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-28.
Sponsored by University of New Hampshire · Observational
This study will include a group of 60 Hispanic adults living in New Hampshire with or without overweight/obesity. The study aims to assess food access and intake of fiber-rich foods, characterize fecal microbiota composition, and assess the relationship between the intake of fiber-rich foods and components of the gut microbiota-gut-brain axis. These aims will be accomplished through biospecimen collection including a pre-collected stool sample, a fasting blood sample, and a Mixed Meal Tolerance Test (MMTT). In addition, participants will answer questionnaires on dietary intake, food insecurity and access, physical activity, eating behavior, and sociodemographic characteristics.
This study will include Hispanic adults living in New Hampshire with or without overweight/obesity. In a group of 60 participants, the study aims to assess food access and intake of fiber-rich foods, characterize fecal microbiota composition, and assess the relationship between the intake of fiber-rich foods and components of the gut microbiota-gut-brain axis.
The study involves biospecimen collection including a pre-collected stool sample, a fasting blood sample, and a Mixed Meal Tolerance Test (MMTT). In addition, participants will answer questionnaires on dietary intake, food insecurity and access, physical activity, eating behavior, and sociodemographic characteristics.
Pre-collected stool samples will be obtained from participants. Anthropometric measurements will be collected at the time of the study visit including height, weight, and waist and hip circumference. BMI will be calculated. An intra-venous catheter will be inserted by a healthcare professional to first collect a fasting blood sample, and will remain inserted for all following blood samples. Subjects will then undergo a Mixed Meal Tolerance Test (MMTT), a validated metabolic assessment in which the participant ingests a liquid mixed meal (e.g., Boost or Ensure), and blood samples are subsequently collected 15min, 30min, 60min and 120min after meal ingestion.
In the intervals between blood sample collections, subjects will complete questionnaires on dietary intake, food insecurity and access, physical activity, eating behavior, and sociodemographic characteristics. The following validated measures will be used to assess these aims:
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 61 is below the median of 114 across 2,154 observational studies indexed under Obesity.
Browse Obesity studies →University of New Hampshire is the lead sponsor of 15 studies on the registry; 4 are open to participants now.
Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →
The study population will be composed of two groups of participants, one group which is composed of participants with a healthy BMI and the other which is composed of overweight/obese participants.
All participants will have self-identified as having an origin or cultural background in a Spanish-speaking country and be between the ages of 18 and 55. All participants will come from SNAP-eligible households. For this study, a SNAP-eligible household is one where the household income is 150% of the national poverty level.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Two groups of participants will be recruited:
Other inclusion criteria are as follows:
Exclusion Criteria:
Adults reporting any of the following conditions will be excluded from the study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A group of 30 Hispanic/Latino adults who are NH residents residing in SNAP-eligible households, and have a BMI between 20 and 25 kg/m2.
A group of 30 Hispanic/Latino adults who are NH residents residing in SNAP-eligible households, and have a BMI greater than or equal to 28 kg/m2.
Food Insecurity and Access
Food insecurity scores will be generated at the household and individual level. Objective measures of food environment and access will be calculated using a modified version of the Retail Food environment Index (RFEI) that focuses on government assistance food sources within a radius around individuals' residential address (e.g., pantries, stores selling fresh food, SNAP retailers). Perceived food environment and access scores will be obtained from the NEMS-P. This questionnaire includes questions about food purchasing habits, priorities for food purchasing choices, characteristics of the local food environment including food availability at retailers and vendors, and food availability at home.
Time frame: August 2022 to August 2023
Fiber Intake
Fiber intake will be calculated using validated analytical pipelines of the NHANES DSQ, developed at the National Cancer Institute. This methodology will be used to calculate predicted daily intakes of total fiber. The PI has previously used this methodology with Hispanic older adults. A comprehensive list of specific fiber-rich foods routinely consumed will be compiled, which will enable the identification of opportunities to increase local fiber-rich food production and consumption by highlighting foods commonly consumed by NH Hispanics (or gaps in current diets that could be fulfilled with local foods).
Time frame: August 2022 to August 2023
Microbial Richness
Microbial richness (number of different taxonomic groups per sample) will be established using Dirichlet multinomial mixtures. Relative abundance of bacterial groups (e.g., at the species, genus, phylum level) will also be calculated.
Time frame: August 2022 to August 2023
Short-Chain Fatty Acids
The SCFA assessment will focus on total SCFA, butyrate, acetate, and propionate. SCFA analysis will be measured using gas chromatography coupled with flame ionization detection.
Time frame: August 2022 to August 2023
LPS
The concentration of lipopolysaccharides (LPS) in the blood, a measure of gut permeability, will be measured. High circulating LPS, known as metabolic endotoxemia, is associated with insulin resistance, obesity, and other metabolic complications.
Time frame: August 2022 to August 2023
Insulin
Insulin levels will be measured using an enzyme-linked immunoassay (ELISA). The levels will be measured both from a fasting blood sample, and during MMTT. The fasting level will be used to for the calculation of the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR).
Time frame: August 2022 to August 2023
Glucose
Fasting glucose level will be used to for the calculation of the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR).
Time frame: August 2022 to August 2023
GLP-1
The levels of GLP-1 will be measured using an enzyme-linked immunoassay (ELISA). The levels of this hormone will be measured both from a fasting blood sample, and during MMTT.
Time frame: August 2022 to August 2023
Ghrelin
The levels of ghrelin will be measured using an enzyme-linked immunoassay (ELISA). The levels of this hormone will be measured both from a fasting blood sample, and during MMTT.
Time frame: August 2022 to August 2023
Fruit, Vegetable, and Whole Grain Intake
Fruit, vegetable, and whole grain intake will be calculated using validated analytical pipelines of the NHANES DSQ, developed at the National Cancer Institute. These methodologies will be used to calculate predicted daily intakes of servings of fruits, vegetables, vegetables including legumes, and whole grains.
Time frame: August 2022 to August 2023
Enterotype Classification of Gut Microbiota
Individual enterotype classification of gut microbiota, a measure of the dominant taxonomic groups per individual, will be established using Dirichlet multinomial mixtures.
Time frame: August 2022 to August 2023
Plan to share: No — IPD will not be shared with other researchers. Final data and results will be published and disseminated.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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University of New Hampshire